Comparison of Two Stapled Antimesenteric Anastomosis for CD: a Randomized Control Trial Study

Not Applicable

Recruiting

• Conditions: Crohn Disease; Recurrence
• Interventions: Procedure: Kono-S group; Procedure: Side-to-side group

• Registration Number: NCT05658081
• Lead Sponsor: Jinling Hospital, China

Brief Summary

The postoperative recurrence of Crohn's diseases (CD) remains high. Stapled anti-mesenteric functional end-to-end anastomosis was safe for CD patients. Its impact on the postoperative recurrence of CD was unknown. Whether it is superior than the conventional anastomosis (stapled antimesenteric isoperistaltic side-to-side anastomosis) needs explored. The trial aims to compare the different impacts of the two antimesenteric anastomosis configurations on the anastomotic recurrence following bowel resection.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-12
• Study First Submitted: 2022-12-02
• Study Start: 2022-12-08
• Study First Submitted QC: 2022-12-17
• Last Update Submitted: 2022-12-17
• Study First Posted: 2022-12-20
• Last Update Posted: 2022-12-20
• Primary Completion: 2024-12
• Study Completion: 2029-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 236

Inclusion Criteria

• patients with Crohn's disease needing bowel resection and anastomosis;
• ileocolic anastomosis；
• written consent acquired

Exclusion Criteria

• patients underwent enterostomy;
• small bowel anastomosis;
• anticipating other trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Kono-S group	Kono-S group	patients in this arm will receive stapled Kono-S anastomosis after bowel resection
Side-to-side group	Side-to-side group	patients in this arm will receive stapled antimesenteric isoperistaltic side-to-side anastomosis after bowel resection

Primary Outcome Measures

Name	Time	Method
the endoscopic recurrence rate at 1 year after surgery	at 1 year after surgery(6-18month)	the endoscopic recurrence rate at 1 year after surgery

Secondary Outcome Measures

Name	Time	Method
the clinical recurrence rate at 1 and 5 year after surgery	1 and 5 year after surgery	the clinical recurrence rate at 1 and 5 year after surgery
the endoscopic recurrence rate at 1 year after surgery	1 and 5 year after surgery	the endoscopic recurrence rate at 1 year after surgery
quality of life for CD patients Short Form 12	1 and 5 year after surgery	Short Form 12 ， higher means better，Short Form-12， 0-12；
the surgical recurrence rate at 1 and 5 year after surgery	1 and 5 year after surgery	the surgical recurrence rate at 1 and 5 year after surgery
quality of life for CD patients inflammatory bowel disease questionnaire(IBDQ)	1 and 5 year after surgery	IBDQ ， higher means better，IBDQ，7-224；

Trial Locations

Locations (1)

Department of General Surgery, Jinling hosptal,Medical School of Nanjing University; 🇨🇳 Nanjing, Jiangsu, China